Dallas, Texas 05/05/2014 (FINANCIALSTRENDS) – Delcath Systems, Inc. (NASDAQ:DCTH) the oncology drug major and medical device developer which holds ownership of the proprietary Melphalan Hepatic Delivery Systems has reported that it will announce its first quarter results on May 7, 2014.
Wonder therapy:Liver cancer chemotherapy
Delcath Systems, Inc. (NASDAQ:DCTH) path-breaking drugs such as the Melphalan Hepatic Delivery System which is used along with MelphalanHydrocholride for Injection is used for chemotherapeutics for treating cancer of the liver. The advantage with this drug is that the exposure to agents is systemically controlled.
Food and Drug Administration regulatedMelphalan or HDS system is used exclusively for the treatment of primary as well as metastatic cancer cells in the liver.
Melphalan is currently used only in combination with another drug or device products and continues to be regulated by FDA for treatment of malignant liver, by way of chemotherapy.
Delcath Systems, Inc. (NASDAQ:DCTH) is currently under the scanner by both FDA and detractors for its Melblez kit.
Melblez Kit has been developed for the treatment of ‘unresectable, hepatic dominant metastatic ocular melanoma.’
The positives of clinical efficacy, hepatic progression free survival are downplayed by the fact that there is no significant improvement in progression-free survival or overall survival.
Most important are the safety concerns on four counts: 7% deaths due to toxicity as well as adverse cardiovascular events. This was despite organ isolation. There is a school of thought amongst Melblez Kit observers that myelosuppression was a common issue in the sample participants for this therapy. The notable condition was called neutropenia, very similar to a condition which is developed if higher dosages of the same drug were to be used.
The next most important concern raised was the condition of melphalan leak to the Gastro Intestinal tract.
As Delcath Systems will now have to wait out FDA approval as safety issues appear to erase much of the clinical advantages Melbel Kit currently offers for treatment of the particular cancer type.